Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA"
FDA Recall Z-2314-2008 · Posted 2008-09-20
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Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2008-07-02
Date Terminated2011-06-07
Product Quantity3,733
Reason for Recall
Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.
Firm Action
Starting July 3, 2008 the firm issued a "MEDICAL DEVICE CORRECTION" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter that is being recalled. Technical Support will be available for customer questions and technical questions and to ensure each unit is upgraded.
Contact Spacelabs Healthcare at 425-657-7200 ext 5970 if you have questions.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide and Worldwide to medical facilities.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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